CWA 16642:2013

This CEN Workshop Agreement (CWA) describes the basic principles of quality criteria for health checks. Quality criteria for health checks aim: — to allow clients to make informed choices about health checks, — to improve beneficence in prevention and early detection of health risks and disease, — to protect individuals against potential adverse consequences (maleficence) of health checks and — to ensure the quality of the health checks. Although the CWA aimed for a set of generic criteria, outside the scope of the CWA are: — screening services covered by the recommendations of the Council of the EU on cancer screening, EXAMPLE The European Union has published quality assurance guidelines for screening for breast-, colorectal and cervical cancer [1-4]. — health checks, national screening programmes or other preventive and prophylactic services already regulated by national or EU legislation and rules, EXAMPLE Prenatal screening programmes and the statutory German health check-up comply with national regulations. — products such as self-tests already covered by national or EU legislation and rules, EXAMPLE Self-tests such as pregnancy tests are covered by Directive 98/79/EC. — indicated testing as offered within the health care system. EXAMPLE Genetic testing for Huntington's disease is indicated when one or more family members are affected.